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Buccolam

Active substance: Midazolam

midazolam

Centralised EU authorisationActive

Marketing holder: Neuraxpharm Pharmaceuticals S.L.

Verified 2026-10-09 · EMA

Analogues in other countries
Composition
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
US 77
  • MIDAZOLAM IN 0.8% SODIUM CHLORIDE
    INJECTION, SOLUTION · MIDAZOLAM 1 mg/mL
    0264-8002
    B. Braun Medical Inc.
  • MIDAZOLAM IN 0.8% SODIUM CHLORIDE
    INJECTION, SOLUTION · MIDAZOLAM 1 mg/mL
    0264-8005
    B. Braun Medical Inc.
  • Midazolam
    INJECTION, SOLUTION · MIDAZOLAM HYDROCHLORIDE 2 mg/2mL
    76045-001
    Fresenius Kabi USA, LLC
  • Midazolam
    INJECTION, SOLUTION · MIDAZOLAM HYDROCHLORIDE 5 mg/mL
    83270-173
    Onesource Specialty Pharma Limited
  • Midazolam
    INJECTION, SOLUTION · MIDAZOLAM HYDROCHLORIDE 5 mg/mL
    83270-175
    Onesource Specialty Pharma Limited
All products in this country (77)
Import and control

Control by country

  • United StatescontrolledSchedule: CIV

    Source: openFDA NDC · record 01a1208c-3096-7a22-b8b9-944e695de7aa,01a1208c-3b41-7f21-9dcc-4e3bcb02aab2,01a1208c-3b43-703a-bf13-52f4179782f7,01a1208c-423e-7a24-85f8-e0b2b25dd787,01a1208c-88b7-7e55-a8c1-f5821a0ae1d2;count=77 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/002267
Registration status
Active
ATC code
N05CD08
Sources
  • product · EMA · EMEA/H/C/002267 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/002267 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/002267 · Verified 2026-10-09